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Global Regulatory Affairs Manager
A company is looking for a Global Regulatory Affairs Manager. Key Responsibilities: Develop and implement regulatory filing timelines for new and existing products in key markets Prepare and submit global market device applications and amendments Lead global regulatory assessments for product and manufacturing process changes Required Qualifications: Bachelor's degree in Science, Engineering, Regulatory Affairs, or related fields 8-10+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience Extensive experience writing US, EU, and other key market submissions Experience with international medical device regulations and standards RAC certification is a plus
A company is looking for a Global Regulatory Affairs Manager.
Key Responsibilities:
Develop and implement regulatory filing timelines for new and existing products in key markets
Prepare and submit global market device applications and amendments
Lead global regulatory assessments for product and manufacturing process changes
Required Qualifications:
Bachelor's degree in Science, Engineering, Regulatory Affairs, or related fields
8-10+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience
Extensive experience writing US, EU, and other key market submissions
Experience with international medical device regulations and standards
RAC certification is a plus